Compilation of the Social Security Laws

(1) In general.—In order for payment to be available under section 1903(a) or under part
B of title XVIII for covered outpatient drugs of a manufacturer, the
manufacturer must have entered into and have in effect a rebate agreement
described in subsection (b) with the Secretary, on behalf of States
(except that, the Secretary may authorize a State to enter directly
into agreements with a manufacturer), and must meet the requirements
of paragraph (5) (with respect to drugs purchased by a covered entity
on or after the first day of the first month that begins after the
date of the enactment of title VI of the Veterans Health Care Act
of 1992[188]) and paragraph (6). Any agreement between
a State and a manufacturer prior to April 1, 1991, shall be deemed
to have been entered into on January 1, 1991, and payment to such
manufacturer shall be retroactively calculated as if the agreement
between the manufacturer and the State had been entered into on January
1, 1991. If a manufacturer has not entered into such an agreement
before March 1, 1991, such an agreement, subsequently entered into,
shall become effective as of the date on which the agreement is entered
into or, at State option, on any date thereafter on or before the
first day of the calendar quarter that begins more than 60 days after
the date the agreement is entered into.

(2) Effective
date.—Paragraph (1) shall first apply
to drugs dispensed under this title on or after January 1, 1991.

(3) Authorizing
payment for drugs not covered under rebate agreements.—Paragraph (1), and section 1903(i)(10)(A), shall not apply
to the dispensing of a single source drug or innovator multiple source
drug if (A)(i) the State has made a determination that the availability
of the drug is essential to the health of beneficiaries under the
State plan for medical assistance; (ii) such drug has been given a
rating of 1-A by the Food and Drug Administration; and (iii)(I) the
physician has obtained approval for use of the drug in advance of
its dispensing in accordance with a prior authorization program described
in subsection (d), or (II) the
Secretary has reviewed and approved the State’s determination
under subparagraph (A); or (B) the Secretary determines that in the
first calendar quarter of 1991, there were extenuating circumstances.

(4) Effect
on existing agreements.—In the case of
a rebate agreement in effect between a State and a manufacturer on
the date of the enactment of this section[189], such agreement, for the initial agreement period specified
therein, shall be considered to be a rebate agreement in compliance
with this section with respect to that State, if the State agrees
to report to the Secretary any rebates paid pursuant to the agreement
and such agreement provides for a minimum aggregate rebate of 10 percent
of the State’s total expenditures under the State plan for coverage
of the manufacturer’s drugs under this title. If, after the
initial agreement period, the State establishes to the satisfaction
of the Secretary that an agreement in effect on the date of the enactment
of this section provides for rebates that are at least as large as
the rebates otherwise required under this section, and the State agrees
to report any rebates under the agreement to the Secretary, the agreement
shall be considered to be a rebate agreement in compliance with the
section for the renewal periods of such agreement.

(A) Agreement with secretary.—A manufacturer
meets the requirements of this paragraph if the manufacturer has entered
into an agreement with the Secretary that meets the requirements of
section 340B of the Public Health Service Act[190] with respect
to covered outpatient drugs purchased by a covered entity on or after
the first day of the first month that begins after the date of the
enactment of this paragraph[191].

(B) Covered entity defined.—In this subsection,
the term “covered entity” means an entity described in
section 340B(a)(4) of the Public Health Service Act

(C) Establishment of alternative mechanism to ensure against duplicate
discounts or rebates.—If the Secretary
does not establish a mechanism under section 340B(a)(5)(A) of the
Public Health Service Act within 12 months of the date of the enactment
of such section[192], the following requirements shall
apply:

(i) Entities.—Each covered entity shall inform the single State agency under
section 1902(a)(5) when it is seeking reimbursement from the State plan for medical
assistance described in section 1905(a)(12) with respect to a unit
of any covered outpatient drug which is subject to an agreement under
section 340B(a) of such Act.

(ii) State
agency.—Each such single State agency
shall provide a means by which a covered entity shall indicate on
any drug reimbursement claims form (or format, where electronic claims
management is used) that a unit of the drug that is the subject of
the form is subject to an agreement under section 340B of such Act,
and not submit to any manufacturer a claim for a rebate payment under
subsection (b) with respect to such a drug.

(D) Effect of subsequent amendments.—In
determining whether an agreement under subparagraph (A) meets the
requirements of section 340B of the Public Health Service Act, the
Secretary shall not take into account any amendments to such section
that are enacted after the enactment of title VI of the Veterans Health
Care Act of 1992[193].

(E) Determination of compliance.—A manufacturer
is deemed to meet the requirements of this paragraph if the manufacturer
establishes to the satisfaction of the Secretary that the manufacturer
would comply (and has offered to comply) with the provisions of section
340B of the Public Health Service Act (as in effect immediately after
the enactment of this paragraph, and would have entered into an agreement
under such section (as such section was in effect at such time), but
for a legislative change in such section after the date of the enactment
of this paragraph.

(6) Requirements
relating to master agreements for drugs procured by department of
veterans affairs and certain other federal agencies.—

(A) In general.—A manufacturer meets the
requirements of this paragraph if the manufacturer complies with the
provisions of section 8126 of title 38, United States Code [194], including
the requirement of entering into a master agreement with the Secretary
of Veterans Affairs under such section.

(B) Effect of subsequent amendments.—In
determining whether a master agreement described in subparagraph (A)
meets the requirements of section 8126 of title 38, United States
Code, the Secretary shall not take into account any amendments to
such section that are enacted after the enactment of title VI of the
Veterans Health Care Act of 1992[195].

(C) Determination of compliance.—A manufacturer
is deemed to meet the requirements of this paragraph if the manufacturer
establishes to the satisfaction of the Secretary that the manufacturer
would comply (and has offered to comply) with the provisions of section
8126 of title 38, United States Code (as in effect immediately after
the enactment of this paragraph) and would have entered into an agreement
under such section (as such section was in effect at such time), but
for a legislative change in such section after the date of the enactment
of this paragraph.

(A) Single source drugs.—In order for payment
to be available under section 1903(a) for a covered outpatient drug
that is a single source drug that is physician administered under
this title (as determined by the Secretary), and that is administered
on or after January 1, 2006, the State shall provide for the collection
and submission of such utilization data and coding (such as J-codes
and National Drug Code numbers) for each such drug as the Secretary
may specify as necessary to identify the manufacturer of the drug
in order to secure rebates under this section for drugs administered
for which payment is made under this title.

(i) Identification
of most frequently physician administered multiple source drugs.—Not later than January 1, 2007, the Secretary shall publish
a list of the 20 physician administered multiple source drugs that
the Secretary determines have the highest dollar volume of physician
administered drugs dispensed under this title. The Secretary may modify
such list from year to year to reflect changes in such volume.

(ii) Requirement.—In order for payment to be available under section 1903(a) for a covered
outpatient drug that is a multiple source drug that is physician administered
(as determined by the Secretary), that is on the list published under
clause (i), and that is administered on or after January 1, 2008,
the State shall provide for the submission of such utilization data
and coding (such as J-codes and National Drug Code numbers) for each
such drug as the Secretary may specify as necessary to identify the
manufacturer of the drug in order to secure rebates under this section.

(C) Use of ndc codes.—Not later than January
1, 2007, the information shall be submitted under subparagraphs (A)
and (B)(ii) using National Drug Code codes unless the Secretary specifies
that an alternative coding system should be used.

(D) Hardship waiver.—The Secretary may
delay the application of subparagraph (A) or (B)(ii), or both, in
the case of a State to prevent hardship to States which require additional
time to implement the reporting system required under the respective
subparagraph.

(A) In general.—A rebate agreement under
this subsection shall require the manufacturer to provide, to each
State plan approved under this title, a rebate for a rebate period
in an amount specified in subsection (c) for covered outpatient drugs
of the manufacturer dispensed after December 31, 1990, for which payment
was made under the State plan for such period. Such rebate shall be
paid by the manufacturer not later than 30 days after the date of
receipt of the information described in paragraph (2) for the period
involved , including such drugs dispensed to individuals enrolled
with a medicaid managed care organization if the organization is responsible
for coverage of such drugs.

(B) Offset against medical assistance.—Amounts received by a State under this section (or under an agreement
authorized by the Secretary under subsection (a)(1) or an agreement
described in subsection (a)(4)) in any quarter shall be considered
to be a reduction in the amount expended under the State plan in the
quarter for medical assistance for purposes of section 1903(a)(1).

(i) In
general.—In addition to the amounts applied
as a reduction under subparagraph (B), for rebate periods beginning
on or after January 1, 2010, during a fiscal year, the Secretary shall
reduce payments to a State under section 1903(a) in the manner specified in clause (ii), in an amount
equal to the product of—

(I) 100 percent
minus the Federal medical assistance percentage applicable to the
rebate period for the State; and

(II) the amounts
received by the State under such subparagraph that are attributable
(as estimated by the Secretary based on utilization and other data)
to the increase in the minimum rebate percentage effected by the amendments
made by subsections (a)(1), (b), and (d) of section 2501 of the Patient
Protection and Affordable Care Act, taking into account the additional
drugs included under the amendments made by subsection (c) of section
2501 of such Act.

The Secretary shall adjust such payment reduction for a calendar
quarter to the extent the Secretary determines, based upon subsequent
utilization and other data, that the reduction for such quarter was
greater or less than the amount of payment reduction that should have
been made.

(ii) Manner
of payment reduction.—The amount of the
payment reduction under clause (i) for a State for a quarter shall
be deemed an overpayment to the State under this title to be disallowed
against the State’s regular quarterly draw for all Medicaid
spending under section 1903(d)(2). Such a disallowance is not subject to a reconsideration under section 1116(d).

(A) State responsibility.—Each State agency
under this title shall report to each manufacturer not later than
60 days after the end of each rebate period and in a form consistent
with a standard reporting format established by the Secretary, information
on the total number of units of each dosage form and strength and
package size of each covered outpatient drug dispensed after December
31, 1990, for which payment was made under the plan during the period,
including such information reported by each medicaid managed care
organization,’’ after ‘‘for which payment
was made under the plan during the period,and shall promptly transmit
a copy of such report to the Secretary.

(B) Audits.—A manufacturer may audit the
information provided (or required to be provided) under subparagraph
(A). Adjustments to rebates shall be made to the extent that information
indicates that utilization was greater or less than the amount previously
specified.

(A) In general.—Each manufacturer with
an agreement in effect under this section shall report to the Secretary—

(i) not later than
30 days after the last day of each month of a rebate period under
the agreement—

(I) on the average
manufacturer price (as defined in subsection (k)(1), customary prompt
pay discounts extended to wholesalers, for covered outpatient drugs
for the rebate period under the agreement (including for all such
drugs that are sold under a new drug application approved under section
505(c) of the Federal Food, Drug, and Cosmetic Act); and

(II) for single
source drugs and innovator mutiple source drugs (including all such
drugs that are sold under a new drug application approved under section
505(c) of the Federal Food, Drug, and Cosmetic Act), on the manufacturer’s
best price (as defined in subsection (c)(1)(C)) for such such drugs
for the rebate period under the agreement;

(ii) not later than
30 days after the date of entering into an agreement under this section
on the average manufacturer price (as defined in subsection (k)(1))
as of October 1, 1990 for each of the manufacturer’s covered
outpatient drugs (including for such drugs that are sold under a new
drug application approved under section 505(c) of the Federal Food,
Drug, and Cosmetic Act); and

(iii) for calendar
quarters beginning on or after January 1, 2004, in conjunction with
reporting required under clause (i) and by National Drug Code (including
package size)—

(I) the manufacturer’s
average sales price (as defined in section 1847A(c)) and the total number of units
specified under section 1847A(b)(2)(A);

(II) if required
to make payment under section 1847A, the manufacturer’s wholesale
acquisition cost, as defined in subsection (c)(6) of such section;
and

(III) information
on those sales that were made at a nominal price or otherwise described
in section 1847A(c)(2)(B);

(IV) not
later than 30 days after the last day of each month of a rebate period
under the agreement, on the manufacturer’s total number of units
that are used to calculate the monthly average manufacturer price
for each covered outpatient drug;

Information reported under this subparagraph is subject to audit
by the Inspector General of the Department of Health and Human Services.
Beginning July 1, 2006, the Secretary shall provide on a monthly basis
to States under subparagraph (D)(iv) the most recently reported average
manufacturer prices for single source drugs and for multiple source
drugs and shall, on at least a quarterly basis, update the information
posted on the website under subparagraph (D)(v), (relating to the
weighted average of the most recently reported monthly average manufacturer
prices) and, for calendar quarters beginning on or after January 1,
2007 and only with respect to the information described in subclause
(III), for covered outpatient drugs.

(B) Verification surveys of average manufacturer price.—The Secretary may survey wholesalers and manufacturers that
directly distribute their covered outpatient drugs, when necessary,
to verify manufacturer prices reported under subparagraph (A). The
Secretary may impose a civil monetary penalty in an amount not to
exceed $100,000 on a wholesaler, manufacturer, or direct seller, if
the wholesaler, manufacturer, or direct seller of a covered outpatient
drug refuses a request for information about charges or prices by
the Secretary in connection with a survey under this subparagraph
or knowingly provides false information. The provisions of section 1128A (other than subsections
(a) (with respect to amounts of penalties or additional assessments)
and (b)) shall apply to a civil money penalty under this subparagraph
in the same manner as such provisions apply to a penalty or proceeding
under section 1128A(a).

(i) Failure
to provide timely information.—In the
case of a manufacturer with an agreement under this section that fails
to provide information required under subparagraph (A) on a timely
basis, the amount of the penalty shall be increased by $10,000 for
each day in which such information has not been provided and such
amount shall be paid to the Treasury, and, if such information is
not reported within 90 days of the deadline imposed, the agreement
shall be suspended for services furnished after the end of such 90-day
period and until the date such information is reported (but in no
case shall such suspension be for a period of less than 30 days).

(ii) False
information.—Any manufacturer with an
agreement under this section that knowingly provides false information
is subject to a civil money penalty in an amount not to exceed $100,000
for each item of false information. Such civil money penalties are
in addition to other penalties as may be prescribed by law. The provisions
of section 1128A (other than subsections (a) and (b)) shall apply to a civil money
penalty under this subparagraph in the same manner as such provisions
apply to a penalty or proceeding under section 1128A(a).

(D) Confidentiality of information.—Notwithstanding
any other provision of law, information disclosed by manufacturers
or wholesalers under this paragraph or under an agreement with the
Secretary of Veterans Affairs described in subsection (a)(6)(A)(ii)
is confidential and shall not be disclosed by the Secretary or the
Secretary of Veterans Affairs or a State agency (or contractor therewith)
in a form which discloses the identity of a specific manufacturer
or wholesaler, prices charged for drugs by such manufacturer or wholesaler,
except—

(i) as the Secretary
determines to be necessary to carry out this section,

(ii) to permit the
Comptroller General to review the information provided,

(iii) to permit
the Director of the Congressional Budget Office to review the information
provided,

(v) to the Secretary
to disclose (through a website accessible to the public) the weighted
average of the most recently reported monthly average manufacturer
prices and the average retail survey price determined for each multiple
source drug in accordance with subsection
(f).

(A) In general.—A rebate agreement shall
be effective for an initial period of not less than 1 year and shall
be automatically renewed for a period of not less than one year unless
terminated under subparagraph (B).

(i) By
the secretary.—The Secretary may provide
for termination of a rebate agreement for violation of the requirements
of the agreement or other good cause shown. Such termination shall
not be effective earlier than 60 days after the date of notice of
such termination. The Secretary shall provide, upon request, a manufacturer
with a hearing concerning such a termination, but such hearing shall
not delay the effective date of the termination.

(ii) By
a manufacturer.—A manufacturer may terminate
a rebate agreement under this section for any reason. Any such termination
shall not be effective until the calendar quarter beginning at least
60 days after the date the manufacturer provides notice to the Secretary.

(iii) Effectiveness of termination.—Any termination
under this subparagraph shall not affect rebates due under the agreement
before the effective date of its termination.

(iv) Notice
to states.—In the case of a termination
under this subparagraph, the Secretary shall provide notice of such
termination to the States within not less than 30 days before the
effective date of such termination.

(v) Application
to terminations of other agreements.—The provisions of this subparagraph shall apply to the terminations
of agreements described in section 340B(a)(1) of the Public Health
Service Act and master agreements described in section 8126(a) of
title 38, United States Code.[196]

(C) Delay before reentry.—In the case of
any rebate agreement with a manufacturer under this section which
is terminated, another such agreement with the manufacturer (or a
successor manufacturer) may not be entered into until a period of
1 calendar quarter has elapsed since the date of the termination,
unless the Secretary finds good cause for an earlier reinstatement
of such an agreement.

(A) In general.—Except as provided in paragraph
(2), the amount of the rebate specified in this subsection for a rebate
period (as defined in subsection (k)(8)) with respect to each dosage
form and strength of a single source drug or an innovator multiple
source drug shall be equal to the product of—

(i) the total number
of units of each dosage form and strength paid for under the State
plan in the rebate period (as reported by the State); and

(I) In general.—In the case of a single
source drug or an innovator multiple source drug described in subclause
(II), the minimum rebate percentage for rebate periods specified in
clause (i)(VI) is 17.1 percent.

(II) Drug described.—For purposes of subclause
(I), a single source drug or an innovator multiple source drug described
in this subclause is any of the following drugs:

(aa) A clotting
factor for which a separate furnishing payment is made under section
1842(o)(5) and which is included on a list of such factors specified
and updated regularly by the Secretary.

(bb) A drug
approved by the Food and Drug Administration exclusively for pediatric
indications.

(i) In
general.—The term “best price” means, with respect to a single source drug or innovator multiple
source drug of a manufacturer (including the lowest price available
to any entity for any such drug of a manufacturer that is sold under
a new drug application approved under section 505(c) of the Federal,
Food, Drug, and Cosmetic Act[197]), the lowest price available
from the manufacturer during the rebate period to any wholesaler,
retailer, provider, health maintenance organization, nonprofit entity,
or governmental entity within the United States, excluding—

(I) any prices
charged on or after October 1, 1992, to the Indian Health Service,
the Department of Veterans Affairs, a State home receiving funds under
section 1741 of title 38, United States Code[198] , the Department of
Defense, the Public Health Service, or a covered entity described
in subsection (a)(5)(B) (including inpatient prices charged to hospitals
described in section 340B(a)(4)(L) of the Public Health Service Act[199]);

(II) any prices
charged under the Federal Supply Schedule of the General Services
Administration;

(III) any
prices used under a State pharmaceutical assistance program;

(IV) any depot
prices and single award contract prices, as defined by the Secretary,
of any agency of the Federal Government;

(V) the prices
negotiated from drug manufacturers for covered discount card drugs
under an endorsed discount card program under section 1860D-31; and

(VI) any prices
charged which are negotiated by a prescription drug plan under part
D of title XVIII, by an MA-PD plan under part C of such title with
respect to covered part D drugs or by a qualified retiree prescription
drug plan (as defined in section 1860D-22(a)(2)) with respect to
such drugs on behalf of individuals entitled to benefits under part
A or enrolled under part B of such title, or any discounts provided
by manufacturers under the Medicare coverage gap discount program
under section 1860D–14A .

(I) shall be
inclusive of cash discounts, free goods that are contingent on any
purchase requirement, volume discounts, and rebates (other than rebates
under this section);

(II) shall
be determined without regard to special packaging, labeling, or identifiers
on the dosage form or product or package;

(III) shall
not take into account prices that are merely nominal in amount; and

(IV) in the
case of a manufacturer that approves, allows, or otherwise permits
any other drug of the manufacturer to be sold under a new drug application
approved under section 505(c) of the Federal Food, Drug, and Cosmetic
Act, shall be inclusive of the lowest price for such authorized drug
available from the manufacturer during the rebate period to any manufacturer,
wholesaler, retailer, provider, health maintenance organization, nonprofit
entity, or governmental entity within the United States, excluding
those prices described in subclauses (I) through (IV) of clause (i).

(iii) Application of auditing and recordkeeping requirements.—With respect to a covered entity described in section 340B(a)(4)(L)
of the Public Health Service Act, any drug purchased for inpatient
use shall be subject to the auditing and recordkeeping requirements
described in section 340B(a)(5)(C) of the Public Health Service Act[200].

(i) In
general.—For purposes of subparagraph
(C)(ii)(III) and subsection (b)(3)(A)(iii)(III), only sales by a manufacturer
of covered outpatient drugs at nominal prices to the following shall
be considered to be sales at a nominal price or merely nominal in
amount:

(I) A covered
entity described in section 340B(a)(4) of the Public Health Service
Act.

(aa) is described
in section 501(c)(3) of the Internal Revenue Code of 1986[201] and exempt from tax under section 501(a) of such Act or is State-owned
or operated; and

(bb) would be
a covered entity described in section 340B(a)(4) of the Public Health
Service Act insofar as the entity described in such section provides
the same type of services to the same type of populations as a covered
entity described in such section provides, but does not receive funding
under a provision of law referred to in such section;

(V) A public
or nonprofit entity, or an entity based at an institution of higher
learning whose primary purpose is to provide health care services
to students of that institution, that provides a service or services
described under section 1001(a) of the Public Health Service Act,
42 U.S.C. 300.

(VI) Any other
facility or entity that the Secretary determines is a safety net provider
to which sales of such drugs at a nominal price would be appropriate
based on the factors described in clause (ii).

(ii) Factors.—The factors described in this clause with respect to a facility
or entity are the following:

(IV) The number
of other facilities or entities eligible to purchase at nominal prices
in the same service area.

(iii) Nonapplication.—Clause (i) shall not
apply with respect to sales by a manufacturer at a nominal price of
covered outpatient drugs pursuant to a master agreement under section
8126 of title 38, United States Code.

(iv) Rule of Construction.—Nothing in this subparagraph shall be construed to alter any
existing statutory or regulatory prohibition on services with respect
to an entity described in clause (i)(IV), including the prohibition
set forth in section 300a-6 of this title.

(A) In general.—The amount of the rebate
specified in this subsection for a rebate period, with respect to
each dosage form and strength of a single source drug or an innovator
multiple source drug, shall be increased by an amount equal to the
product of—

(i) the total number
of units of such dosage form and strength dispensed after December
31, 1900, for which payment was made under the State plan for the
rebate period; and

(I) the average
manufacturer price for the dosage form and strength of the drug for
the period, exceeds

(II) the average
manufacturer price for such dosage form and strength for the calendar
quarter beginning July 1, 1990 (without regard to whether or not the
drug has been sold or transferred to an entity, including a division
or subsidiary of the manufacturer, after the first day of such quarter),
increased by the percentage by which the consumer price index for
all urban consumers (United States city average) for the month before
the month in which the rebate period begins exceeds such index for
September 1990.

(B) Treatment of subsequently approved drugs.—In the case of a covered outpatient drug approved by the Food
and Drug Administration after October 1, 1990, clause (ii)(II) of
subparagraph (A) shall be applied by substituting “the first
full calendar quarter after the day on which the drug was first marketed” for “the calendar quarter beginning July 1, 1990” and “the month prior to the first month of the first full calendar quarter
after the day on which the drug was first marketed” for “September 1990”.

(C) Treatment of new formulations.—In the
case of a drug that is a line extension of a single source drug or
an innovator multiple source drug that is an oral solid dosage form,
the rebate obligation with respect to such drug under this section
shall be the amount computed under this section for such new drug
or, if greater, the product of—

(i) the average manufacturer
price of the line extension of a single source drug or an innovator
multiple source drug that is an oral solid dosage form;

(ii) the highest
additional rebate (calculated as a percentage of average manufacturer
price) under this section for any strength of the original single
source drug or innovator multiple source drug; and

(iii) the total
number of units of each dosage form and strength of the line extension
product paid for under the State plan in the rebate period (as reported
by the State). In this subparagraph, the term “line extension” means, with respect to a drug, a new formulation of the drug, such
as an extended release formulation.

In this subparagraph, the term “line extension” means, with respect to a drug, a new formulation of the drug, such
as an extended release formulation.

(D) Maximum rebate amount.—In no case shall
the sum of the amounts applied under paragraph (1)(A)(ii) and this
paragraph with respect to each dosage form and strength of a single
source drug or an innovator multiple source drug for a rebate period
beginning after December 31, 2009, exceed 100 percent of the average
manufacturer price of the drug.

(A) In general.—The amount of the rebate
paid to a State for a rebate period with respect to each dosage form
and strength of covered outpatient drugs (other than single source
drugs and innovator multiple source drugs) shall be equal to the product
of—

(i) the applicable
percentage (as described in subparagraph (B)) of the average manufacturer
price for the dosage form and strength for the rebate period, and

(ii) the total number
of units of such dosage form and strength dispensed after December
31, 1990, for which payment was made under the State plan for the
rebate period.

(iii) the drug
is subject to such restrictions pursuant to an agreement between a
manufacturer and a State authorized by the Secretary under subsection
(a)(1) or in effect pursuant to subsection
(a)(4); or

(iv) the State has
excluded coverage of the drug from its formulary established in accordance
with paragraph (4).

(2)[202] List of drugs subject to restriction.—The following drugs or classes of drugs, or their medical uses,
may be excluded from coverage or otherwise restricted:

(G) Nonprescription
drugs, except, in the case of pregnant women when recommended in accordance
with the Guideline referred to in section 1905(bb)(2)(A), agents approved
by the Food and Drug Administration under the over-the-counter monograph
process for purposes of promoting, and when used to promote, tobacco
cessation.

(H) Covered outpatient
drugs which the manufacturer seeks to require as a condition of sale
that associated tests or monitoring services be purchased exclusively
from the manufacturer or its designee.

(K) Agents when
used for the treatment of sexual or erectile dysfunction, unless such
agents are used to treat a condition, other than sexual or erectile
dysfunction, for which the agents have been approved by the Food and
Drug Administration.

(3) Update
of drug listings.—The Secretary shall,
by regulation, periodically update the list of drugs or classes of
drugs described in paragraph (2) or their medical uses, which the
Secretary has determined, based on data collected by surveillance
and utilization review programs of State medical assistance programs,
to be subject to clinical abuse or inappropriate use.

(4) Requirements
for formularies.—A State may establish
a formulary if the formulary meets the following requirements:

(A) The formulary
is developed by a committee consisting of physicians, pharmacists,
and other appropriate individuals appointed by the Governor of the
State (or, at the option of the State, the State’s drug use
review board established under subsection (g)(3)).

(B) Except as
provided in subparagraph (C), the formulary includes the covered outpatient
drugs of any manufacturer which has entered into and complies with
an agreement under subsection (a) (other than any drug excluded from
coverage or otherwise restricted under paragraph (2)).

(C) A covered
outpatient drug may be excluded with respect to the treatment of a
specific disease or condition for an identified population (if any)
only if, based on the drug’s labeling (or, in the case of a
drug the prescribed use of which is not approved under the Federal
Food, Drug, and Cosmetic Act[203] but is a medically accepted indication,
based on information from the appropriate compendia described in subsection
(k)(6)), the excluded drug does not have a significant, clinically
meaningful therapeutic advantage in terms of safety, effectiveness,
or clinical outcome of such treatment for such population over other
drugs included in the formulary and there is a written explanation
(available to the public) of the basis for the exclusion.

(D) The State
plan permits coverage of a drug excluded from the formulary (other
than any drug excluded from coverage or otherwise restricted under
paragraph (2)) pursuant to a prior authorization program that is consistent
with paragraph (5).

(E) The formulary
meets such other requirements as the Secretary may impose in order
to achieve program savings consistent with protecting the health of
program beneficiaries.

A prior authorization program established by a State under paragraph
(5) is not a formulary subject to the requirements of this paragraph.

(5) Requirements
of prior authorization programs.—A State
plan under this title may require, as a condition of coverage or payment
for a covered outpatient drug for which Federal financial participation
is available in accordance with this section, with respect to drugs
dispensed on or after July 1, 1991, the approval of the drug before
its dispensing for any medically accepted indication (as defined in subsection (k)(6)) only if the system
providing for such approval—

(A) provides
response by telephone or other telecommunication device within 24
hours of a request for prior authorization; and

(B) except with
respect to the drugs on the list referred to in paragraph (2), provides
for the dispensing of at least 72-hour supply of a covered outpatient
prescription drug in an emergency situation (as defined by the Secretary).

(6) Other
permissible restrictions.—A State may
impose limitations, with respect to all such drugs in a therapeutic
class, on the minimum or maximum quantities per prescription or on
the number of refills, if such limitations are necessary to discourage
waste, and may address instances of fraud or abuse by individuals
in any manner authorized under this Act.

(7)[204] Non-excludable drugs.—The following drugs or classes of drugs, or their medical uses, shall
not be excluded from coverage:

(A) Agents when
used to promote smoking cessation, including agents approved by the
Food and Drug Administration under the over-the-counter monograph
process for purposes of promoting, and when used to promote, tobacco
cessation.

(1) In general.—During the period beginning on January 1, 1991, and ending on
December 31, 1994—

(A) a State may
not reduce the payment limits established by regulation under this
title or any limitation described in paragraph (3) with respect to
the ingredient cost of a covered outpatient drug or the dispensing
fee for such a drug below the limits in effect as of January 1, 1991,
and

(B) except as
provided in paragraph (2), the Secretary may not modify by regulation
the formula established under sections 447.331 through 447.334 of
title 42, Code of Federal Regulations[205], in effect on November
5, 1990, to reduce the limits described in subparagraph (A).

(2) Special
rule.—If a State is not in compliance
with the regulations described in paragraph (1)(B), paragraph (1)(A)
shall not apply to such State until such State is in compliance with
such regulations.

(3) Effect
on state maximum allowable cost limitations.—This section shall not supersede or affect provisions in effect
prior to January 1, 1991, or after December 31, 1994, relating to
any maximum allowable cost limitation established by a State for payment
by the State for covered outpatient drugs, and rebates shall be made
under this section without regard to whether or not payment by the
State for such drugs is subject to such a limitation or the amount
of such a limitation.

(4) Establishment
of upper payment Limits.—Subject to paragraph
(5), the Secretary shall establish a Federal upper reimbursement limit
for each multiple source drug for which the FDA has rated three or
more products therapeutically and pharmaceutically equivalent, regardless
of whether all such additional formulations are rated as such and
shall use only such formulations when determining any such upper limit.

(5) Use
of amp in upper payment limits.—The Secretary
shall calculate the Federal upper reimbursement limit established
under paragraph (4) as no less than 175 percent of the weighted average
(determined on the basis of utilization) of the most recently reported
monthly average manufacturer prices for pharmaceutically and therapeutically
equivalent multiple source drug products that are available for purchase
by retail community pharmacies on a nationwide basis. The Secretary
shall implement a smoothing process for average manufacturer prices.
Such process shall be similar to the smoothing process used in determining
the average sales price of a drug or biological under section 1847A.

(f) Survey
of Retail Prices; State Payment and Utilization Rates and Performance
Rankings.—

(i) with respect
to a retail community pharmacy, the determination on a monthly basis
of retail survey prices for covered outpatient drugs that represent
a nationwide average of consumer purchase prices for such drugs, net
of all discounts and rebates (to the extent any information with respect
to such discounts and rebates is available); and

(ii) the notification
of the Secretary when a drug product that is therapeutically and pharmaceutically
equivalent and bioequivalent becomes generally available.

(B) Secretary response to notification of availability of multiple source
products.—If contractor notifies the
Secretary under subparagraph (A)(ii) that a drug product described
in such subparagraph has become generally available, the Secretary
shall make a determination, within 7 days after receiving such notification,
as to whether the product is now described in subsection (e)(4).

(C) Use of competitive bidding.—In contracting
for such services, the Secretary shall competitively bid for an outside
vendor that has a demonstrated history in—

(ii) working with
retail pharmacies, commercial payers, and States in obtaining and
disseminating such price information; and

(iii) collecting
and reporting such price information on at least a monthly basis.

In contracting for such services, the Secretary may waive such
provisions of the Federal Acquisition Regulation as are necessary
for the efficient implementation of this subsection, other than provisions
relating to confidentiality of information and such other provisions
as the Secretary determines appropriate.

(D) Additional provisions.—A contract with
a vendor under this paragraph shall include such terms and conditions
as the Secretary shall specify, including the following:

(i) The vendor must
monitor the marketplace and report to the Secretary each time there
is a new covered outpatient drug generally available.

(ii) The vendor
must update the Secretary no less often than monthly on the retail
survey prices for covered outpatient drugs.

(E) Availability of information to states.— Information on retail survey prices obtained under this paragraph,
including applicable information on single source drugs, shall be
provided to States on at least a monthly basis. The Secretary shall
devise and implement a means for providing access to each State agency
designated under section 1902(a)(5) with responsibility for the administration or supervision
of the administration of the State plan under this title of the retail
survey price determined under this paragraph.

(2) Annual
state report.—Each State shall annually
report to the Secretary information on—

(A) the payment
rates under the State plan under this title for covered outpatient
drugs;

(A) Comparative analysis.—The Secretary
annually shall compare, for the 50 most widely prescribed drugs identified
by the Secretary, the national retail sales price data (collected
under paragraph (1)) for such drugs with data on prices under this
title for each such drug for each State.

(B) Availability of information.—The Secretary
shall submit to Congress and the States full information regarding
the annual rankings made under subparagraph (A).

(4) Appropriation.—Out of any funds in the Treasury not otherwise appropriated,
there is appropriated to the Secretary of Health and Human Services
$5,000,000 for each of fiscal years 2006 through 2010 to carry out
this subsection.

(A) In order
to meet the requirement of section 1903(i)(10)(B), a State shall provide,
by not later than January 1, 1993, for a drug use review program described
in paragraph (2) for covered outpatient drugs in order to assure that
prescriptions (i) are appropriate, (ii) are medically necessary, and
(iii) are not likely to result in adverse medical results. The program
shall be designed to educate physicians and pharmacists to identify
and reduce the frequency of patterns of fraud, abuse, gross overuse,
or inappropriate or medically unnecessary care, among physicians,
pharmacists, and patients, or associated with specific drugs or groups
of drugs, as well as potential and actual severe adverse reactions
to drugs including education on therapeutic appropriateness, overutilization
and underutilization, appropriate use of generic products, therapeutic
duplication, drug-disease contraindications, drug-drug interactions,
incorrect drug dosage or duration of drug treatment, drug-allergy
interactions, and clinical abuse/misuse.

(B) The program
shall assess data on drug use against predetermined standards, consistent
with the following:

(C) The Secretary,
under the procedures established in section 1903, shall pay to each State an amount
equal to 75 per centum of so much of the sums expended by the State
plan during calendar years 1991 through 1993 as the Secretary determines
is attributable to the statewide adoption of a drug use review program
which conforms to the requirements of this subsection.

(D) States shall
not be required to perform additional drug use reviews with respect
to drugs dispensed to residents of nursing facilities which are in
compliance with the drug regimen review procedures prescribed by the
Secretary for such facilities in regulations implementing section 1919, currently at section
483.60 of title 42, Code of Federal Regulations[206].

(2) Description
of program.—Each drug use review program
shall meet the following requirements for covered outpatient drugs:

(i) The State plan
shall provide for a review of drug therapy before each prescription
is filled or delivered to an individual receiving benefits under this
title, typically at the point-of-sale or point of distribution. The
review shall include screening for potential drug therapy problems
due to therapeutic duplication, drug-disease contraindications, drug-drug
interactions (including serious interactions with nonprescription
or over-the-counter drugs), incorrect drug dosage or duration of drug
treatment, drug-allergy interactions, and clinical abuse/misuse. Each
State shall use the compendia and literature referred to in paragraph
(1)(B) as its source of standards for such review.

(ii) As part of
the State’s prospective drug use review program under this subparagraph
applicable State law shall establish standards for counseling of individuals
receiving benefits under this title by pharmacists which includes
at least the following:

(I) The pharmacist
must offer to discuss with each individual receiving benefits under
this title or caregiver of such individual (in person, whenever practicable,
or through access to a telephone service which is toll-free for long-distance
calls) who presents a prescription, matters which in the exercise
of the pharmacist’s professional judgment (consistent with State
law respecting the provision of such information), the pharmacist
deems significant including the following:

Nothing in this clause shall be construed as requiring a pharmacist
to provide consultation when an individual receiving benefits under
this title or caregiver of such individual refuses such consultation,
or to require verification of the offer to provide consultation or
a refusal of such offer.

(B) Retrospective drug use review.—The
program shall provide, through its mechanized drug claims processing
and information retrieval systems (approved by the Secretary under
section 1903(r)) or otherwise, for the ongoing periodic examination of claims data
and other records in order to identify patterns of fraud, abuse, gross
overuse, or inappropriate or medically unnecessary care, among physicians,
pharmacists and individuals receiving benefits under this title, or
associated with specific drugs or groups of drugs.

(C) Application of standards.—The program
shall, on an ongoing basis, assess data on drug use against explicit
predetermined standards (using the compendia and literature referred
to in subsection[207] (1)(B) as the source
of standards for such assessment) including but not limited to monitoring
for therapeutic appropriateness, overutilization and underutilization,
appropriate use of generic products, therapeutic duplication, drug-disease
contraindications, drug-drug interactions, incorrect drug dosage or
duration of drug treatment, and clinical abuse/misuse and, as necessary,
introduce remedial strategies, in order to improve the quality of
care and to conserve program funds or personal expenditures.

(D) Educational program.—The program shall,
through its State drug use review board established under paragraph
(3), either directly or through contracts with accredited health care
educational institutions, State medical societies or State pharmacists
associations/societies or other organizations as specified by the
State, and using data provided by the State drug use review board
on common drug therapy problems, provide for active and ongoing educational
outreach programs (including the activities described in paragraph
(3)(C)(iii) of this subsection) to educate practitioners on common
drug therapy problems with the aim of improving prescribing or dispensing
practices.

(A) Establishment.—Each State shall provide
for the establishment of a drug use review board (hereinafter referred
to as the “DUR Board”) either directly or through a contract
with a private organization.

(B) Membership.—The membership of the DUR
Board shall include health care professionals who have recognized
knowledge and expertise in one or more of the following:

The membership of the DUR Board shall be made up at least 1/3 but no more than 51 percent licensed
and actively practicing physicians and at least 1/3 ***[208] licensed and actively practicing pharmacists.

(C) Activities.—The activities of the DUR
Board shall include but not be limited to the following:

(iii) Ongoing interventions
for physicians and pharmacists, targeted toward therapy problems or
individuals identified in the course of retrospective drug use reviews
performed under this subsection. Intervention programs shall include,
in appropriate instances, at least:

(I) information
dissemination sufficient to ensure the ready availability to physicians
and pharmacists in the State of information concerning its duties,
powers, and basis for its standards;

(II) written,
oral, or electronic reminders containing patient-specific or drug-specific
(or both) information and suggested changes in prescribing or dispensing
practices, communicated in a manner designed to ensure the privacy
of patient-related information;

(III) use
of face-to-face discussions between health care professionals who
are experts in rational drug therapy and selected prescribers and
pharmacists who have been targeted for educational intervention, including
discussion of optimal prescribing, dispensing, or pharmacy care practices,
and follow-up face-to-face discussions; and

(IV) intensified
review or monitoring of selected prescribers or dispensers.

The Board shall re-evaluate interventions after an appropriate
period of time to determine if the intervention improved the quality
of drug therapy, to evaluate the success of the interventions and
make modifications as necessary.

(D) Annual report.—Each State shall require
the DUR Board to prepare a report on an annual basis. The State shall
submit a report on an annual basis to the Secretary which shall include
a description of the activities of the Board, including the nature
and scope of the prospective and retrospective drug use review programs,
a summary of the interventions used, an assessment of the impact of
these educational interventions on quality of care, and an estimate
of the cost savings generated as a result of such program. The Secretary
shall utilize such report in evaluating the effectiveness of each
State’s drug use review program.

(1) In general.—In accordance with chapter 35 of title 44, United States Code
(relating to coordination of Federal information policy), the Secretary
shall encourage each State agency to establish, as its principal means
of processing claims for covered outpatient drugs under this title,
a point-of-sale electronic claims management system, for the purpose
of performing on-line, real time eligibility verifications, claims
data capture, adjudication of claims, and assisting pharmacists (and
other authorized persons) in applying for and receiving payment.

(A) for calendar
quarters during fiscal years 1991 and 1992, expenditures under the
State plan attributable to development of a system described in paragraph
(1) shall receive Federal financial participation under section 1903(a)(3)(A)(i) (at a matching rate of 90 percent) if the State acquires, through
applicable competitive procurement process in the State, the most
cost-effective telecommunications network and automatic data processing
services and equipment; and

(B) the Secretary
may permit, in the procurement described in subparagraph (A) in the
application of part 433 of title 42, Code of Federal Regulations,
and parts 95, 205, and 307 of title 45, Code of Federal Regulations,
the substitution of the State’s request for proposal in competitive
procurement for advance planning and implementation documents otherwise
required.

(1) In general.—Not later than May 1 of each year the Secretary shall transmit
to the Committee on Finance of the Senate, the Committee on Energy
and Commerce of the House of Representatives, and the Committees on
Aging of the Senate and the House of Representatives a report on the
operation of this section in the preceding fiscal year.

(1) Covered outpatient
drugs are not subject to the requirements of this section if such
drugs are—

(A) dispensed
by health maintenance organizations, including Medicaid managed care
organizations that contract under section 1903(m); and subject to
discounts under section 340B of the Public Health Service Act.

(B) subject to
discounts under section 340B of the Public Health Service Act.

(2) The State plan
shall provide that a hospital (providing medical assistance under
such plan) that dispenses covered outpatient drugs using drug formulary
systems, and bills the plan no more than the hospital’s purchasing
costs for covered outpatient drugs (as determined under the State
plan) shall not be subject to the requirements of this section.

(3) Nothing in this
subsection shall be construed as providing that amounts for covered
outpatient drugs paid by the institutions described in this subsection
should not be taken into account for purposes of determining the best
price as described in subsection (c).

(A) In general.—Subject to subparagraph
(B), the term “average manufacturer price” means, with
respect to a covered outpatient drug of a manufacturer for a rebate
period, the average price paid to the manufacturer for the drug in
the United States by—.

(i) wholesalers for
drugs distributed to retail community pharmacies; and

(ii) retail community
pharmacies that purchase drugs directly from the manufacturer.

(III) reimbursement
by manufacturers for recalled, damaged, expired, or otherwise unsalable
returned goods, including (but not limited to) reimbursement for the
cost of the goods and any reimbursement of costs associated with return
goods handling and processing, reverse logistics, and drug destruction;

(IV) payments
received from, and rebates or discounts provided to, pharmacy benefit
managers, managed care organizations, health maintenance organizations,
insurers, hospitals, clinics, mail order pharmacies, long term care
providers, manufacturers, or any other entity that does not conduct
business as a wholesaler or a retail community pharmacy[211]

(ii) Inclusion
of other discounts and payments.—Notwithstanding
clause (i), any other discounts, rebates, payments, or other financial
transactions that are received by, paid by, or passed through to,
retail community pharmacies shall be included in the average manufacturer
price for a covered outpatient drug.

(C) Inclusion of 505(c) drugs.—In the case
of a manufacturer that approves, allows, or otherwise permits any
drug of the manufacturer to be sold under a new drug application approved
under section 505(c) of the Federal Food, Drug, and Cosmetic Act,
such term shall be inclusive of the average price paid for such drug
by wholesalers for drugs distributed to the retail community pharmacies.

(2) Covered
outpatient drug.—Subject to the exceptions
in paragraph (3), the term “covered outpatient drug” means—

(A) of those
drugs which are treated as prescribed drugs for purposes of section 1905(a)(12), a
drug which may be dispensed only upon prescription (except as provided
in paragraph (5)), and—

(i) which is approved
for safety and effectiveness as a prescription drug under section
505 or 507 of the Federal Food, Drug, and Cosmetic Act[213] or which is approved under section 505(j) of such Act;

(ii)(I) which was
commercially used or sold in the United States before the date of
the enactment of the Drug Amendments of 1962 or which is identical,
similar, or related (within the meaning of section 310.6(b)(1) of
title 21 of the Code of Federal Regulations[214]) to such a drug, and (II) which has not been the subject
of a final determination by the Secretary that it is a “new
drug” (within the meaning of section 201(p) of the Federal
Food, Drug, and Cosmetic Act[215]) or an action brought by the Secretary
under section 301, 302(a), or 304(a) of such Act to enforce section
502(f) or 505(a) of such Act; or

(iii)(I) which
is described in section 107(c)(3) of the Drug Amendments of 1962 and
for which the Secretary has determined there is a compelling justification
for its medical need, or is identical, similar, or related (within
the meaning of section 310.6(b)(1) of title 21 of the Code of Federal
Regulations) to such a drug, and (II) for which the Secretary has
not issued a notice of an opportunity for a hearing under section
505(e) of the Federal Food, Drug, and Cosmetic Act on a proposed order
of the Secretary to withdraw approval of an application for such drug
under such section because the Secretary has determined that the drug
is less than effective for some or all conditions of use prescribed,
recommended, or suggested in its labeling; and

(3) Limiting
definition.—The term “covered outpatient
drug” does not include any drug, biological product, or insulin
provided as part of, or as incident to and in the same setting as,
any of the following (and for which payment may be made under this
title as part of payment for the following and not as direct reimbursement
for the drug):

Such term also does not include any such drug or product for
which a National Drug Code number is not required by the Food and
Drug Administration or a drug or biological[216] used for a medical indication which is not a medically
accepted indication. Any drug, biological product, or insulin excluded
from the definition of such term as a result of this paragraph shall
be treated as a covered outpatient drug for purposes of determining
the best price (as defined in subsection (c)(1)(C)) for such drug,
biological product, or insulin.

(4) Nonprescription
drugs.—If a State plan for medical assistance
under this title includes coverage of prescribed drugs as described
in section 1905(a)(12) and permits coverage of drugs which may be sold without a prescription
(commonly referred to as “over-the-counter” drugs), if
they are prescribed by a physician (or other person authorized to
prescribe under State law), such a drug shall be regarded as a covered
outpatient drug.

(5) Manufacturer.—The term “manufacturer” means any entity which
is engaged in—

(A) the production,
preparation, propagation, compounding, conversion, or processing of
prescription drug products, either directly or indirectly by extraction
from substances of natural origin, or independently by means of chemical
synthesis, or by a combination of extraction and chemical synthesis,
or

(B) in the packaging,
repackaging, labeling, relabeling, or distribution of prescription
drug products.

Such term does not include a wholesale distributor of drugs
or a retail pharmacy licensed under State law.

(6) Medically
accepted indication.—The term “medically accepted indication” means any use for a covered
outpatient drug which is approved under the Federal Food, Drug, and
Cosmetic Act[217], or the use of which is supported by one or more citations
included or approved for inclusion in any of the compendia described
in subsection (g)(1)(B)(i).

(i) Multiple
source drug.—The term “multiple
source drug” means, with respect to a rebate period, a covered
outpatient drug (not including any drug described in paragraph (5))
for which [218]there at least 1 other drug product
which—

(I) is rated
as therapeutically equivalent (under the Food and Drug Administration’s
most recent publication of “Approved Drug Products with Therapeutic
Equivalence Evaluations”),

(II) except
as provided in subparagraph (B), is pharmaceutically equivalent and
bioequivalent, as defined in subparagraph (C) and as determined by
the Food and Drug Administration, and

(ii) Innovator
multiple source drug.—The term “innovator multiple source drug” means a multiple source drug
that was originally marketed under an original new drug application
approved by the Food and Drug Administration.

(iv) Single
source drug.—The term “single source
drug” means a covered outpatient drug which is produced or
distributed under an original new drug application approved by the
Food and Drug Administration, including a drug product marketed by
any cross-licensed producers or distributors operating under the new
drug application.

(B) Exception.—Subparagraph (A)(i)(II)
shall not apply if the Food and Drug Administration changes by regulation
the requirement that, for purposes of the publication described in
subparagraph (A)(i)(I), in order for drug products to be rated as
therapeutically equivalent, they must be pharmaceutically equivalent
and bioequivalent, as defined in subparagraph (C).

(i) drug products
are pharmaceutically equivalent if the products contain identical
amounts of the same active drug ingredient in the same dosage form
and meet compendial or other applicable standards of strength, quality,
purity, and identity; and

(ii) drugs are bioequivalent
if they do not present a known or potential bioequivalence problem,
or, if they do present such a problem, they are shown to meet an appropriate
standard of bioequivalence.

(8) Rebate
period.—The term “rebate period” means, with respect to an agreement under subsection (a), a calendar quarter or other period specified
by the Secretary with respect to the payment of rebates under such
agreement.

(9) State
agency.—The term “State agency” means the agency designated under section 1902(a)(5) to administer or supervise
the administration of the State plan for medical assistance.

(10) Retail
community pharmacy.—The term “retail
community pharmacy” means an independent pharmacy, a chain
pharmacy, a supermarket pharmacy, or a mass merchandiser pharmacy
that is licensed as a pharmacy by the State and that dispenses medications
to the general public at retail prices. Such term does not include
a pharmacy that dispenses prescription medications to patients primarily
through the mail, nursing home pharmacies, long-term care facility
pharmacies, hospital pharmacies, clinics, charitable or not-for-profit
pharmacies, government pharmacies, or pharmacy benefit managers.

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